FDA 483 OBSERVATION · #1565 OF 1,916 MOST-CITED
Lack of certification of conformance
FDA cited this observation 7 times across 6 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
What this grouping is not
An observation-type page groups FDA’s published citation records. The grouping, the compliance steps and the root causes are SPEQ synthesis, not an FDA classification of any citation, and a count measures what FDA published rather than risk.
How FDA worded it — real examples
Failure to furnish to the dealer, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Failure to furnish to the distributor, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Failure to furnish to the dealer and distributor, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Failure to furnish to the dealer and distributor, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Failure to furnish to the dealer, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Failure to furnish to the dealer and distributor, at the time of delivery of a product, a certification that the product conforms to all applicable standards.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. Open the 483 observation explorer →